药物不良反应 ///

ADVERSE DRUG
REACTION
了解风险和影响 ///
Understanding the Risks and Implications

作者： Precious Junorm P. Fulgarinas ， RPh

目录 /// Table of contents
ADR 和
ADR Ade 的
和 Ade 的 药物不良反应的危
药物不良反应的危
1 定义
定义 ///
of
/// Definition
of ADR
Definition
ADR andand ADE
ADE
3 险因素
险因素 ///
Factors
/// Risk
Factors for
Risk
for ADRs
ADRs

药品不良反应分类 药品不良反应的原
药品不良反应的原
2 /// Classification
of ADR
4 因因 ///
/// Causes
Causes of
ADR
ADR
of
 介绍 ///
Introduction
 01
定义 ///
DEFINITIONS
ADR AND ADE
ADR 和 ADE
 定义 /// 药物不良反应 /// ADVERSE
DRUG REACTION
DEFINITION 对有害的和非预期的药物的反应，
并且在通常用于人类预防、诊断或
治 疗 疾 病 的 剂 量 下 发 生 。 ///
response to a drug that is noxious
and unintended, and that occurs
at doses normally used in
humans for prophylaxis ,
diagnosis, or therapy of disease .
 定义 /// 药物不良事件 ///
ADVERSE DRUG EVENT
DEFINITION
是患者在使用药物后出现的不良结
果，但可能与药物的使用有关，也
可 能 无 关 。 /// is an adverse
outcome in a patient, which
occurs after the use of a drug, but
which may or may not be linked to
use of the drug.
 副作用： /// SIDE-EFFECT
定义 ///
DEFINITION 预期的、众所周知的反应，导
致患者管理变化很小或没有变
化。该效应具有“可预测的频
率 ” 。 /// Expected, well-known
reaction resulting in little or no
change in patient
management. The effect has a
“predictable frequency”.
 ADR VS ADE /// ADR 与 ADE
可预防的 ///
无法预防 ///
PREVENTABLE and 无
UNPREVENTABLE 法预防 ///
UNPREVENTABLE

无意的 /// 故意的 ///

INTENTIONAL and
UNINTENTIONAL 无意的 ///
UNINTENTIONAL
所有 ADR 都是 Ade ，但并非
所有 Ade 都是 ADR. /// all
ADRs are ADEs, but not all
ADEs will be ADRs.

记得！ ///
REMEMBER!
 QUESTION NO. 1?

WHAT DO YOU THINK? WHY ALL ADRs

CONSIDERED ADEs AND NOT ALL ADEs ARE
CONIDERED ADRs?

你觉得怎么样？为什么所有 ADR 都被视为 ADEs ，

而不是所有 ADE 都是被蚕食的 ADR ？
 ANSWER
based on the definitions , all _____
ADRs fall under the
category of _____
ADEs because they represent harmful
drug-related events. However not all ADEs are ADRs
because ADEs include a broader range of harmful
outcomes, including medication errors and other factors
unrelated to the drug’s properties .
根据这些定义，所有 _____ 都属于 _____ 类别，因为它们代表了与
毒品有关的有害事件。然而，并非所有 ADE 都是 ADR ，因为 ADE
包括更广泛的有害结果，包括用药错误和其他与药物特性无关的因
素 。
ACTIVITY 1: IDENTIFY WHICH COLUMN IS ADR, ADE AND SIDE EFFECTS

ADR SIDE EFFECT ADE

药物不良反应 副作用 药物不良事件
Normal dose and Normal dose and related May or may not be
unrelated or related to to pharmacological linked to use of the
drug’s pharmacology properties of the drug.
正常剂量且与药物药理无 drug ./// 正常剂量与药物的药理学 可能与药物的使用有关，也可能
关或相关 性质有关 与药物的使用无关。

UNINTENDED UNINTENDED INTENTIONAL AND

意外 意外 UNINTENTIONAL
有意和无意

NOXIOUS PREDICTABLE FREQUENCY 可预防的 ///

有毒 “ 可预测的频率”。 PREVENTABLE and 无法预
防 /// UNPREVENTABLE
 总 结：
药物不良反应、药物不良事件、副作用的
概念；
 2
分类 ///
CLASSIFICATION
药物不良反应 ///
ADVERSE DRUG
REACTION
 CLASSIFICATION OF ADR /// 药品不良反应分类

DEPENDING UPON; /// 取决于；

 TYPE OF REACTIONS /// 反应类型

Type: A,B,C,D,E,F /// 类型： A,B,C,D,E,F
 ONSET OF EVENT /// 事件开始
Acute (<60minutes), Sub-acute(1-24hrs), Latent(>2 days) /// 急性（ <60
分钟）、亚急性（ 1-24 小时）、潜伏期（ >2 天）
 SEVERITY /// 严重性
Minor, Moderate, Severe, Lethal ADR/// 轻度、中度、重度、致死
性 ADR
 1. TYPES OF ADR /// ADR 的类型

增强的 /// 很奇怪 /// 连续的 ///

AUGMENTED BIZZARE
C
CONTINUOUS

A B
D
F E
FAILURE OF 使用结束 /// 延迟 ///
THERAPY /// F END OF USE DELAYED
型：治疗失败
A D TYPES OF ADR /// ADR 的类型
TYPE A: AUGMENTED ///
型 A ：增强型
B E
C FF  KEY NOTES! /// 关键注意事项！
 DOSE DEPENDENT /// 剂量依赖性
 PREDICTABLE /// 可预测的
 COMMON /// 普通的
 REPRODUCIBLE /// 可再现
 A EXAMPLES /// 例

• Benzodiazepine → SEDATION /// 苯二氮卓类药物→镇静

• Glibenclamide → HYPOGLYCEMIA /// 优降糖→低血糖
• Warfarin → BLEEDING /// 华法林→出血
• Antibiotics → DIARRHEA /// 抗生素→腹泻
• Furosemide → HYPOKALEMIA /// 速尿→低钾血症
 A EXAMPLES /// 例
• Morphine → CONSTIPATION /// 吗啡→便秘 ///
• ACE Inh → COUGH /// ACE INH → 咳嗽
• Minoxidil → HYPERTRICHOSIS /// 米诺地尔→多毛症
• Thiazide → HYPERGLYCEMIA and HYPERURICEMIA ///
噻嗪类→高血糖和高尿酸血症
A D TYPES OF ADR /// ADR 的类型
TYPE B:BIZZARE /// 类型 B

B E  KEY NOTES!! /// 关键注意事项！

 NOT dose related /// 与剂量无关

C F  Unpredictable /// 不可预测

 Rare /// 罕见
 unknown mechanism /// 未知机制
 serious and fatal /// 严重且致命

SUBTYPES /// 亚型
o IDIOSYNCRATIC /// 特质的
o HYPERSENSITIVITY REACTION /// 超敏 反应
///
B o SUBTYPES: IDIOSYNCRATIC/// 亚型：特异型

 Malignant Hyperthermia /// 恶性高热

1. Succinylcholine- muscle relaxant /// 琥珀胆碱 - 肌肉松弛
剂
2. Halothane – inhaled anesthetic /// 氟烷 - 吸入麻醉剂
3. Sevoflurane - inhaled anesthetic /// 七氟烷 - 吸入麻醉剂
 o SUBTYPES: IDIOSYNCRATIC/// 亚型：特异
B 型
 Hemolytic Anemia /// 溶血性贫血
1. G6PD+ Antimalarials /// G6PD+ 抗疟药
2. G6PD + Sulfonamides /// 葡萄糖 -6- 磷
酸脱氢酶 + 磺胺类药物

 Steven Johnsons Syndrome/// 史蒂文

· 约翰逊综合征
1. Carbamazepine /// 卡马西平
2. Phenytoin /// 苯妥英
3. Sulfonamides /// 磺胺类药物
 B
o SUBTYPES : HYPERSENSITIVITY RXN ///
亚型：超敏 反应

TYPES OF HYPERSENSITIVITY RXN

类型 : 超敏 反应
REMEMBER THE MNEMONIC “ACID”
 Type 1 : Anaphylactic/ Immediate /// 类型 1 ：过敏性 / 速
发型
 Type 2 : Cytotoxic /// 第 2 类：细胞毒性
 Type 3 : Immune complex /// 第三类：免疫复合物
 Type 4 : Delayed /// 类型 4 ：延迟
B
TYPES OF HYPERSENSITIVITY RXN /// 类型 ：超敏 反应
Type 1 : Anaphylactic/Immediate
类型 1 ：过敏性 / 速发型

 IgE- mediated anaphylactic reactions/// IgE 介导

A 的过敏反应
C  Penicillin → Anaphylaxis/ allergy /// 青霉素→过敏
反应 / 变态反应
I  Clindamycin → Pseudomembranous colitis /// 克
D 林霉素→伪膜性结肠炎
B TYPES OF HYPERSENSITIVITY RXN /// 类型 ：超敏 反应
 Type 2: Cytotoxic /// 第 2 类：细胞毒
性
 IgG or IgM- mediated cytotoxic reaction /// IgG 或
A IgM 介导的细胞毒性反应
C  Methyldopa → Hemolytic Anemia /// 甲基多巴→溶血
性贫血
I  Chloramphenicol → Aplastic Anemia /// 氯霉素→再
D 生障碍性贫血
B
TYPES OF HYPERSENSITIVITY RXN /// 类型 ：超敏 反应
Type 3 :Immune Complex /// 第三类： 免疫
复合物

IgG- mediated immune complex reactions /// IgG

A 介导的免疫复合物反应
C
 Blood Dyscrasia/// 血液恶液质
I  Arthurs Reaction /// 亚瑟的反应
D  Systemic Lupus erythematosus /// 系统性红斑狼疮
 Steven Johnsons Syndrome /// 史蒂文 · 约翰逊综
合征
B
TYPES OF HYPERSENSITIVITY RXN /// 类型 ：超敏 反应
 Type 4:Delayed or Cell mediated ///
 类型 4 ：延迟或细胞介导
 T Cell-mediated delayed reaction T 细胞介导的延迟反
A 应
C  Occur after delayed period ( typically 24-48hrs) following
exposure to an allergen. /// 在暴露于过敏原后的延迟期（通常为
I 24-48 小时）后发生

D  Contact Dermatitis (poison ivy reaction) /// 接触性皮炎

 Tuberculin Skin Test /// 结核菌素皮肤试验
 Morbilliform Rash /// 麻疹样皮疹
A D TYPES OF ADR /// ADR 的类型
TYPE C: CONTINUOUS ///
类型 C ：连续
B E
C F  KEY NOTES!! /// 关键注意事项！
✓ DOSE related /// 剂量相关
✓ TIME dependent /// 时间相关
✓↑ Duration = ↑ Risk /// ↑ 期限 =
↑ 风险
C TYPE C: CONTINUOUS /// 类型 C ：连续

 DEPENDENCE- Physical Dependence-

craving and compulsive drug-seeking
behavior (body),Psychological Dependence-
abstinence from drug produces physiological
symptoms (mind) Ex: BZD, caffeine,
cocaine /// 依赖 - 身体依赖 - 渴求和强迫性药
物寻求行为（身体），心理依赖 - 戒毒产生生
理症状（精神）例如： BZD ，咖啡因，可卡
因
C TYPE C: CONTINUOUS /// 类型 C ：连续

 ADDICTION- person takes the drug compulsively

Ex: marijuana, opiates /// 成瘾 - 人强迫性地服用药
物，例如：大麻，鸦片制剂

 Tolerance– reduced effect with repeated used of

the drug
Ex: nicotine, nitrates /// 耐受性 - 重复使用药物的影
响降低，例如：尼古丁、硝酸盐
A D
TYPES OF ADR /// ADR 的类型
TYPE D: DELAYED ///
类型 D ：延迟

B E  KEY NOTES!! /// 关键注意事项！

C F ✓ TIME dependent /// 时间相关

EXAMPLE:
 Carcinogenicity /// 致癌性
 Teratogens /// 致畸剂
D
TYPES OF ADR /// ADR 的类型

TYPE D: DELAYED ///

类型 D ：延迟

 Carcinogenicity /// 致癌性

– Antineoplastics /// – 抗肿瘤药
– Heterocyclic Amines – 杂环胺
– Aromatic Hydrocarbons /// - 芳香烃
– Nitrosamines /// – 亚硝胺
– Aflatoxin /// - 黄曲霉毒素
  Teratogens /// 致畸剂
RETINOIDS 维甲酸 HEART AND BRAIN ANOMALIES 心脑异常
PHENYTOIN 苯妥英 FETAL HYDANTOIN SYNDROME 胎儿乙内酰脲综
合征
VALPROIC ACID 丙戊酸 SPINA BIFIDA 脊柱裂
ACE INHIBITOR ACE 抑制剂 RENAL DYSGENESIS 肾发育不全
LITHIUM 锂 EBSTEIN’S ANOMALY 埃布斯坦异常
METHIMAZOLE 甲巯咪唑 APLASIA CUTIS 皮肤发育不全
WARFARIN 华法林 FETAL WARFARIN SYNDROME 胎儿华法林综合征

ALCOHOL 酒精 FETAL ALCOHOL SYNDROME 胎儿酒精综合症

THALIDOMIDE 沙利度胺 PHOCOMELIA 短肢畸形
FETAL HYDANTOIN SYNDROME
 FETAL WARFARIN
SYNDROME 胎儿华法林综合征

APLASIA CUTIS 皮肤发育不全

PHOCOMELIA
短肢畸形 FETAL ALCOHOL
SYNDROME 胎儿酒精综合症
 TYPES OF ADR /// ADR 的类型
A D TYPE E: END OF USE///
E 类：使用结束 ///
B E  KEY NOTES!// 关键注意事项！
C F ✓ 不常见 /// ✓ UNCOMMON
✓ 提款 /// ✓ WITHDRAWAL
 E TYPE E: END OF USE /// E 类：使用结束

➢Opiate Withdrawal → Opioids /// 阿片类戒断→阿片类

➢ Rebound Insomnia → BZD /// 反跳性失眠→ BZD
➢ Rebound Hypertension → Clonidine /// 反跳性高血压→可乐定
➢ Adrenal Crisis → Corticosteroids /// 肾上腺危象→皮质类固醇
➢ Rhinitis Medicamentosa → Nasal decongestant /// 药物性鼻炎→
鼻腔减充血剂
A D TYPES OF ADR /// ADR 的类型
TYPE F: FAILURE OF THERAPY ///
F 型：治疗失败
B E
 KEY NOTES!! 关键注意事项！
C F
✓ unexpected failure of
efficacy /// 意外失效
✓ Common /// 常见
✓ dose-related /// 剂量相关
 TYPE F: FAILURE OF THERAPY /// F 型：治疗失败
F
 Drug-drug Interactions/// 药物相互作用
 Use of Counterfeit Drugs /// 使用假药
 Drug Instability /// 药物不稳定
 Patient’s Non-compliance /// 患者的不依从性
 Wrong Route Of Administration /// 给药途径错
误
 Drug Resistance /// 抗药性
 Expired Drugs /// 过期药品
RECALL : TYPES OF ADR /// ADR 的类型

增强的 /// 很奇怪 /// 连续的 ///

AUGMENTED BIZZARE
C
CONTINUOUS

A B
D
F E
FAILURE OF 使用结束 /// 延迟 ///
THERAPY /// F END OF USE DELAYED
型：治疗失败
ACTIVITY 2: ENUMERATE THE 6 TYPES OF
ADR.

A AUGMENTED
增强的 D DELAYED
延迟

B BIZZARE
很奇怪 E END OF USE
使用结束

FAILURE OF

C
CONTINUOUS
连续的 F THERAPY
治疗失败
 ACTIVITY 3: IDENTIFY WHAT TYPE OF
ADR /// 活动 3 ：确定 ADR 的类型
1.ACE inh → COUGH /// ACE INH → 咳嗽 A
2.Penicillin → Anaphylaxis/ allergy /// 青霉素→过敏反 B
应 / 变态反应

3.Thalidomide 沙利度胺 → phocomelia 短肢畸形

D
4. marijuana, opiates 大麻，鸦片制剂 C
 CLASSIFIED ACCORDING TO THEIR ONSET
根据发病情况分类
The timing of the reaction can be /// 反应的时间可以是
 Acute (occurring within 1 hour of exposure) /// 急性（接触
后 1 小时内发生）
 Subacute (occurring within 24 hours of exposure) /// 亚急
性（接触后 24 小时内发生）
 Latent (appearing 2 or more days after drug exposure). ///
潜伏（药物暴露后 2 天或更长时间出现）。
根据其严重程度分类 /// CLASSIFIED ACCORDING TO THEIR SEVERITY

不需要治疗、解毒剂或延长住院时间

需要改变药物治疗、特定治疗或延长住院时间至少 1 天。

可能危及生命，造成永久性损伤或需要强化治疗

直接或间接导致患者死亡
 3
Risk factors /// 风
险因素
RISK 性别
44 性别 ///
/// GENDER
GENDER
FACTORS /// 风
险因素
1 年龄
年龄 ////// AGE
AGE 共病条件
共病条件 ///
/// COMORBID
55 COMORBID
CONDITIONS
CONDITIONS

合并用药 /// 窄治疗指数药物

02
22 CONCURRENT 66
窄治疗指数药物 //////NARROW
THERAPEUTIC
NARROW
INDEX
THERAPEUTIC INDEX
DRUGS
DRUGS
MEDICINES

治疗持续时间
治疗持续时间 //////
33 DURATION
DURATION OF
OF 77 遗传学
遗传学 ///
/// GENETICS
GENETICS
THERAPY
THERAPY
 11 年龄
年龄 ///
/// AGE
AGE

The very young and the very old are particularly vulnerable to ADRs. Young
children, especially neonates, lack fully developed organs for drug metabolism
and elimination. As children grow, drug dosing can be affected by changes in
bodyweight, drug distribution, and drug elimination. Age-related changes in body
composition and organ function, such as decreased liver and kidney function,
and increased sensitivity to medications predispose the elderly patient to drug
toxicity. Additionally, this population tends to use more drugs and have more
illnesses than younger age groups./// 年龄很小和很大的人特别容易受到药物不良反
应的影响。幼儿，尤其是新生儿，缺乏发育完全的药物代谢和消除器官。随着儿童的成
长，药物剂量会受到体重变化、药物分布和药物消除的影响。与年龄相关的身体成分和器
官功能的变化，如肝肾功能下降，对药物的敏感性增加，使老年患者易发生药物毒性。此
外，与年轻群体相比，这一人群往往使用更多的药物，患有更多的疾病。 ///
 SPECIAL POPULATIONS /// 特殊人群

• Undeveloped organs /// 未发育的器官

• Examples of ADRs in pediatrics associated
with UDP-glucoronosyl acetyltransferase
deficiency are gray baby
PEDIATRICS /// 小儿科 syndrome(chloramphenicol) and
kernicterus(sulfonamides) /// 与尿苷二磷
酸葡萄糖醛酸乙酰基转移酶缺乏相关的儿科
药物不良反应的例子有灰婴综合征（氯霉
素）和核黄疸（磺胺类药物）。

• Comorbidity /// 共病
Polypharmacy /// 多药治疗
GERIATRICS /// 老年病学 •
• Pharmacokinetics 药代动力学
• Less functional organs /// 功能器官较少

PREGANT /// 怀孕的 • TERATOGENIC AGENTS /// 致畸剂

 合并用药
合并用药 //////
2 CONCURRENT
CONCURRENT
MEDICINES
MEDICINES

Taking multiple prescription medicines, over-the-counter drugs, and/or

alternative or natural products increases the risk of experiencing an adverse
drug reaction. The number and severity of adverse reactions increase
disproportionately with the number of drugs taken, and some trials have
found that the best predictor of ADRs is the number of concurrent
medicines. /// 服用多种处方药、非处方药物和 / 或替代品或天然产品会增加
药物不良反应的风险。不良反应的数量和严重程度随着服用药物数量的增加
而不成比例地增加，一些试验发现， ADR 的最佳预测指标是同时服用的药
物数量。
“ 药物相互作用随着医疗产品使用数量的增加
而增加” /// “drug-drug interactions increases
as the number of medical products used
rises”
 33 治疗持续时间
治疗持续时间 ///
THERAPY
/// DURATION
DURATION OF
OF
THERAPY

The greater the degree of drug exposure, the greater the

likelihood an ADR will occur. This is particularly true for
already predisposed persons (the very young and very old),
and or those with existing organ dysfunction such as renal or
hepatic failure. /// 药物暴露程度越高，发生 ADR 的可能性
越大。这对于已经有易感倾向的人（非常年轻和非常年老的
人）和 / 或那些已有器官功能障碍（如肾或肝衰竭）的人来说
尤其如此。
 44 性别
性别 ///
/// GENDER
GENDER

Here are a few reasons why gender is included as a risk factor for
ADRs: /// 以下是将性别列为 ADR 风险因素的几个原因：

1. Biological Differences: Males and females have inherent biological

differences, including variances in body composition, hormonal levels,
organ function, and enzyme activity. These differences can affect the way
medications are processed and metabolized in the body, potentially
leading to variations in ADRs. /// 生物学差异：男性和女性具有固有的生
物学差异，包括身体成分、激素水平、器官功能和酶活性的差异。这些差
异会影响药物在体内的处理和代谢方式，可能导致 ADR 的变化。
 44 性别
性别 ///
/// GENDER
GENDER

2. Hormonal Influences: Hormonal fluctuations throughout the

menstrual cycle, pregnancy, or menopause can influence drug
metabolism, distribution, and receptor sensitivity. These hormonal
influences can contribute to differences in the occurrence or
severity of certain ADRs. /// 激素影响：月经周期、妊娠或绝经期的
激素波动可影响药物代谢、分布和受体敏感性。这些激素的影响可
导致某些药物不良反应的发生或严重程度的差异。 ///
 共病条件
共病条件 ///
5 /// COMORBID
COMORBID
CONDITIONS
CONDITIONS
Patients with concurrent medical problems are more likely to experience
an adverse drug reaction than comparatively healthy persons. Illnesses
such as congestive heart failure, malnutrition, obesity, hepatitis,
cirrhosis, or diabetes can alter the pharmacokinetics and
pharmacodynamics of drugs, leading to drug accumulation and toxicity.
Additionally, such patients are typically using multiple medicines, further
increasing their risk. /// 与相对健康的人相比，同时患有疾病的患者更容
易出现药物不良反应。充血性心力衰竭、营养不良、肥胖、肝炎、肝硬
化或糖尿病等疾病可改变药物的药代动力学和药效学，导致药物蓄积和
毒性。此外，这类患者通常使用多种药物，进一步增加了他们的风险。
 窄治疗指数药物
窄治疗指数药物 /// /// NARROW
NARROW
66 THERAPEUTIC
THERAPEUTIC INDEX
INDEX DRUGS
DRUGS

Majority of ADRs are dose-related, those drugs with little

separation between therapeutic and toxic concentrations
are highly associated with adverse reactions. Examples
include aminoglycosides, anticonvulsants, digoxin, heparin,
theophylline, and warfarin. /// 大多数 ADR 与剂量有关，那
些治疗浓度和毒性浓度几乎没有区别的药物与不良反应高度
相关。实例包括氨基糖苷类、抗惊厥药、地高辛、肝素 , 茶
碱和华法林。
窄治疗指数药物
/// NARROW
THERAPEUTIC
INDEX DRUGS
 遗传学
遗传学 ///
///
77
GENETICS
GENETICS
Inherited or genetic differences can affect drug response, leading
to varied outcomes ranging from desired therapeutic effects to
adverse drug reactions (ADRs). Variability in drug response can
be attributed to genetic variations in drug-metabolizing enzymes,
drug transporters, or drug targets. /// 遗传或基因差异可影响药物
反应，导致从预期治疗效果到药物不良反应（ ADR ）的不同结
果。药物反应的变异性可归因于药物代谢酶、药物转运蛋白或药物
靶标的遗传变异。
RECALL: RISK
FACTORS /// 风险因素 44 性别
性别 ///
/// GENDER
GENDER

1 年龄
年龄 ///
/// AGE
AGE 共病条件
共病条件 ///
/// COMORBID
55 COMORBID
CONDITIONS
CONDITIONS

合并用药 /// 窄治疗指数药物

02
22 CONCURRENT 66
窄治疗指数药物 //////NARROW
THERAPEUTIC
NARROW
INDEX
THERAPEUTIC INDEX
DRUGS
DRUGS
MEDICINES

治疗持续时间
治疗持续时间 //////
33 DURATION
DURATION OF
OF 77 遗传学
遗传学 ///
/// GENETICS
GENETICS
THERAPY
THERAPY
ACTIVITY 3:
GIVE ATLEAST 3
RISK FACTORS
ASSOCIATED
WITH ADR.
给出至少 3 个与
ADR 相关的危险因
素。
 4
CAUSES OF ADR
// 药品不良反应的
原因
常见原因
常见原因 ///
/// COMMON
COMMON
CAUSES
CAUSES

 Failing to take the correct dosages at the correct times

未能在正确的时间服用正确的剂量

 Overdosing 用药过量

 Allergies to chemical components of the medicine

对药物中的化学成分过敏
常见原因
常见原因 ///
/// COMMON
COMMON
CAUSES
CAUSES

 Combining the medicine with alcohol /// 将药物与酒精

结合

 Taking other drugs or preparation that interact with

the medicine. /// 服用其他与药物有相互作用的药物
或制剂。

 Taking a medicine that is prescribed to someone

else. 服用别人开的药。 ///
70-year-old man develops a severe shoulder pain and is diagnosed as having a frozen
shoulder, for which he is prescribed physiotherapy and given naproxen, 250mg 3 times a day,
by his family doctor. The doctor knows him well and checks that he has normal renal function
for his age. When he attends for review about 2 weeks later, he is complaining tiredness and
reduced urine frequency. Over the past few days, he noted painful but non-swollen joints and
maculopapular rash on his trunk and limbs. He is afebrile and apart from the rash there are no
other abnormal physical signs. Laboratory results shows normal full blood count ; an absolute
eosinophil count raised at 490/mm3. His serum creatinine clearance was 110µmol/L at a
baseline and is now 350µmol/L with a urea 22.5mmol/L; Electrolytes and liver function test are
normal . Urinalysis shows 2 + protein, urine microscopy contains 100 leukocytes/high power
feild with 24% eosinophils.
70 岁男子出现严重的肩痛，被诊断为肩周炎，为此，他的家庭医生给他开了物理治疗，并给予
萘普生， 250mg ，每天 3 次。医生很了解他，并检查他的肾功能是否正常。大约 2 周后，当
他参加复查时，他主诉疲倦和尿频减少。在过去的几天里，他注意到他的躯干和四肢上有疼痛
但不肿胀的关节和斑丘疹。他无发热，除皮疹外，没有其他异常体征。实验室结果显示全血细
胞 计 数 正 常 ; 嗜 酸 性 粒 细 胞 绝 对 计 数 升 高 至
490/mm3 。基线时血清肌酐清除率为 110μmol/L ，现在为 350μmol/L ，尿素为 22.5mmol/L;
电解质和肝功能检查正常。尿液分析显示 2 + 蛋白质，尿液显微镜检查含有 100 个白细胞 / 高
能 细 胞 和 24% 嗜 酸 性 粒 细 胞 。
QUESTIONS

1. If this is an ADR, what type of reaction is it and what is the

diagnosis?
1. 如果这是 ADR ，它是什么类型的反应，诊断是什么？

2. What is the best management plan, and should this patient ever
receive naproxen again?
2. 最好的管理方案是什么，这个病人是否应该再次接受萘普生？
QUESTION AND ANSWER
1. If this is an ADR, what type of reaction is it and what is the diagnosis?
1. 如果这是 ADR ，它是什么类型的反应，诊断是什么？

The patient has developed an acute interstitial nephritis, probably secondary

to the recent introduction of naproxen treatment. This is a well-recognized
syndrome, with the clinical features that the patient displays in this case. It
can be associated with many NSAIDs (both nonselective NSAIDs and COX-2
inhibitors), particularly in the elderly. This is a type B adverse drug reaction
whose pathophysiology is probably a combination of type III and type IV
hypersensitivity reactions.
患者出现急性间质性肾炎，可能继发于近期引入萘普生治疗。这是一种公认的综合征，
具有患者在这种情况下表现出的临床特征。它可能与许多非甾体抗炎药（非选择性非甾
体抗炎药和 COX-2 抑制剂）有关，尤其是在老年人中。这是一种 B 型药物不良反
应，其病理生理学可能是 III 型和 IV 型超敏反应的组合。
2. What is the best management plan, and should this patient ever receive
naproxen again?
2. 最好的管理方案是什么，这个病人是否应该再次接受萘普生？

Discontinuation of the offending agent is vital, and this is sometimes sufficient to

produce a return to baseline values of renal function and the disappearance of
systemic symptoms of fever and the rash. Recovery may possibly be accelerated,
and further renal toxicity minimized by a short course (five to seven days) of high-
dose oral corticosteroids, while monitoring renal function. The offending agent
should not be used again in this patient unless the benefits of using it vastly
outweigh the risks associated with its use in a serious illness.

停用致病药物至关重要，这有时足以使肾功能恢复到基线值，并消除发热和皮疹的
全身症状。在监测肾功能的同时，短期（ 5-7 天）口服大剂量皮质类固醇可能会加
速恢复，并将进一步的肾毒性降至最低。除非在严重疾病中使用其益处远远超过与
使用该药物相关的风险，否则不应再次用于该患者。
TAKEAWAYS!
REMEMBER! “all ADRs are ADEs, but not all
ADEs will be ADRs.”
记得！ “所有 ADR 都是 ADE ，但并非所有 ADE
都是 ADR”
REMEMBER! “ABCDEF” (Types of ADR).
记得！“ ABCDEF” （ ADR 类型）。
REMEMBER! “ACID” (Types of hypersensitivity
reactions)
记得！“ ACID” （超敏反应的类型）
 谢谢你
们 ///
Thank
You
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